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A Cognitive Risk Calculator and Screening Tool for Primary Care Settings

A Cognitive Risk Calculator and Screening Tool for Primary Care Settings

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06506877
Enrollment
50
Registered
2024-07-18
Start date
2024-04-03
Completion date
2027-12-31
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Risk Assessment

Brief summary

This mixed-methods pragmatic trial will use a stepped wedge cluster randomized design to implement a cognitive risk-calculator and automated cognitive screening tool (BACH) in eight internal medicine clinics in the Cleveland Clinic Health System. Administrative and EHR data will provide quantitative metrics of adoption (tool use) and effectiveness (change in provider behavior) while observations, interviews, and questionnaires will assess fidelity, acceptability, and feasibility for all stakeholders. Analyses will consider provider characteristics, clinic attributes, and regional variations in patient characteristics (e.g., SES, race/ethnicity).

Interventions

BEHAVIORALImplementation of Cognitive Risk Calculator (RC) and Brief Assessment of Cognitive Health (BACH)

Enrolled providers will have access to two cognitive screening tools during the active phase. The first tool is a Cognitive Risk-Calculator (RC), integrated into the Electronic Health Record, to help providers identify patients who are at high risk of exhibiting cognitive decline. The second tool is a computerized cognitive screening tool, the Brief Assessment of Cognitive Health (BACH), which patients complete independently. Results are automatically entered into the patient's medical record, along with patient-specific flags for concerns about depression and/or sleep disorder. The purpose of these tools is to facilitate cognitive screening and treatment for factors that may be contributing to cognitive decline.

Sponsors

The Cleveland Clinic
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

Provider Inclusion Criteria: * Must see adults aged 60 years or older in their practice. * Must be a prescribing provider.

Exclusion criteria

* Provider sees patients at more than one participating study site.

Design outcomes

Primary

MeasureTime frameDescription
Adoption of RC and BACH: Frequency of Cognitive ScreeningMonthly assessment over the study duration (up to 1 year)Number of cognitive screening events per month, stratified by screening tool (BACH vs other) and Risk Calculator category (high vs low risk).
Adoption of RC and BACH: Frequency of BACH OrdersMonthly assessment over the study duration (up to 1 year)Number of BACH orders or pre-visit order sets executed per month, stratified by Risk Calculator category (high vs low risk).
Effectiveness of RC and BACH: Frequency of MCI/ADRD, Sleep Disorders, and Depression DiagnosesMonthly assessment over the study duration (up to 1 year)Incidence of new diagnoses for cognitive impairment (including MCI and ADRD), sleep disorders, and depression per month, stratified by screening completed (BACH/other/none) and Risk Calculator category (high vs low risk).
Effectiveness of RC and BACH: Frequency of Referrals to Neuropsychology, Geriatrics/Neurology, Psychiatry/Psychology, and Sleep MedicineMonthly assessment over the study duration (up to 1 year)Number of orders and consults placed to specialty services per month, stratified by screening completed (BACH/other/none) and Risk Calculator category (high vs low risk).
Effectiveness of RC and BACH: Prescription Rates for Related MedicationsMonthly assessment over the study duration (up to 1 year)Number of new medication orders relevant to cognition, sleep, and mood per month, stratified by screening completed (BACH/other/none) and Risk Calculator category (high vs low risk).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026